Field of the Invention
The present invention relates to a biological sample collection container and a system to aid in detection and identification of the type of closure and container to facilitate automated processing of the biological sample and collection container.
Description of Related Art
Biological samples, such as blood samples, are typically collected in sample containers, such as blood collection tubes, and transported to a laboratory for analysis.
In many processes for analyzing biological samples, particularly in batch and serial processes where several samples are involved, it is desirable to improve throughput by providing a greater degree of automated control over various stages of the sample handling, preparation, and analysis processes and by providing better management of sample-related data.
In one aspect, instrumentation for the handling, preparation, and analysis of samples has become more automated. For instance, where the analytical instrument requires the blood collection tubes to be open before they are sorted, pretreated, sampled, and tested, the instrument may have an automatic decapping processer to automatically decap blood collection tubes. Many automatic decapping processers rely on an optical vision inspection system using a color charged coupled device (CCD) to confirm the presence of a tube to be decapped.
Automating the decapping of blood collection tubes is further complicated by the variety of available blood collection tubes, which may vary in diameter, height, and especially the variety of available closures to cover the blood collection tubes. Some closures unscrew from threading on the top of the blood collection tubes. These include closures for blood collection tube-specific caps manufactured by Sarstedt® of Germany, Braun, also of Germany, Meditech, Inc. of Bel Air, Md. and Greiner® of Austria. Another type of closure is a rubber stopper inserted into a blood collection tube, such as a Vacutainer® blood collection tube, which is removed by a pulling motion. An additional type of closure has a stopper with an outer shield such as Hemogard™ caps used on Vacutainer® blood collection tubes from Becton, Dickinson and Company. The closures may also differ in their composition—they may be rubber, plastic, etc.
Conventional specimen collection containers used for the collection of biological samples typically include a closure or cap that is color coded to allow medical personnel and/or automated processing systems to visually discern the contents of the collection container. Color coded caps easily and quickly identify the contents of the specimen collection container and/or intended testing procedure of the container to medical personnel and automated processing systems without requiring that a printed label be read to determine the relevant information. For example, a specimen collection container having a red cap may indicate that the contents of the container are to be analyzed for serum-based tests, whereas a specimen collection container having a green cap may indicate that the contents are to be analyzed for plasma-based tests. In certain cases, the color coded caps may indicate that a biological sample has been mixed with certain additive or amount of additive in order to prepare the sample for a certain testing procedure.
As more testing procedures are developed and additional sample preparation additives are employed, the number of colors required for color coded caps has increased. However, by increasing the number of color variations that are used for the caps, it has become increasingly difficult to properly distinguish one color coded cap from another. For example, if a dark green cap is used to identify one testing procedure to be performed on the contents of the container, a medium green cap is used to identify another testing procedure to be performed on the contents of the container, and a light green cap is used to identify yet another testing procedure to be performed on the contents of the container, then the likelihood that one color coded cap may be confused for another color coded cap increases. This is particularly true for automated processes that may have difficulty in distinguishing specific hues within a given color family, i.e., distinguishing dark green from medium green. Inaccuracies in the process of determining cap color can result in the incorrect testing procedure being performed on the contents of a specific specimen collection container. In other instances, specimen collection containers may be inaccurately provided to a specific testing apparatus that is incompatible with the specimen collection container. In other instances, certain closure coloration can sometimes result in difficulty in automatic discrimination of closures by certain optical imaging systems and software—i.e., an optical vision inspection system fails to detect the presence of a closed blood collection tube and therefore fails to, for example, decap the blood collection tube and thereby reduce the throughput.
Furthermore, instrument and automation manufacturers have attempted to use the color of the closure for detection by an optical imaging system and software to automate the sorting of the blood collection tubes into similar types for further downstream analysis. This approach has inherent issues as even subtle color variation of the caps can prevent consistently accurate classification by the optical imaging system.
It would therefore be advantageous to provide an improved inspection system to detect closures without regard to coloration and with the added capability of allowing a more consistent and accurate identification of the type of tube for subsequent sorting and analytical processing.
It would also be advantageous to provide a system for providing a wide range of visual identifiers to easily identify the contents of a specimen collection container and/or the desired testing procedure to be performed on the contents of the specimen collection container. A need further exists to expand the current usage of color coded caps for quickly and easily identifying the contents of the specimen collection container.